Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

Phase 2TerminatedNCT04363827

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS155 enrolled

Overview

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2). The participants will be randomised to receive either: Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).

This is an open label, superiority, cluster-randomized Italian interventional clinical trial, evaluating the role of Hydroxychloroquine versus observation only in preventing infection to COVID-19 or treating early phase COVID-19 patients. Each index case is randomised to either Arm A: Hydroxychloroquine or Arm B: observation in a 2:1 ratio on an open label basis. Participants in the same cluster receive the same intervention. Study population is constituted by: Group 1: Severe Acute Respiratory Syndrome (SARS) - Corona Virus (CoV)-2-exposed subjects , as household members/contacts of COVID-19 patients. Group 2: Patients with COVID-19 asymptomatic or paucisymptomatic in home situation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

COVID19 Hydroxychloroquine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or Female, aged \>= 18 years 2. SARS-CoV-2-exposed subjects, as household members and/or contacts of COVID-19 patients (Group 1). In this group are included Health care professionals in contact with COVID-19 patients. or 3. COVID-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti COVID-19 medication (Group 2) 4. Absence of any COVID-19 symptom in last week before randomization (fever \>37.5°C, cough, dyspnea) (only for group 1 subjects) 5. Paracetamol treatment is accepted only for group 2. 6. Participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct. Exclusion Criteria: 1. Reported anamnesis for: 1. Intolerance or previous toxicity for hydroxychloroquine/chloroquine 2. Bradycardia or reduction rhythm of heart with arrythmias 3. Ischemic heart disease 4. Retinopathy 5. Congestive heart failure under/with use of diuretics 6. Favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency 7. Diabetes type 1 8. Major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy. 9. Severe neurological and mental illness 2. Any other contraindication to take hydroxychloroquine 3. Already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks 4. Use of other antiviral agents in the last 3 weeks 5. Subject with a positive test for SARS-CoV-2 (for Group 1) 6. Pregnant or lactating 7. Current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, Cyclosporine, Phenylbutazone, drugs that inhibit CYP2D6 8. Known prolonged QT syndrome or current use of drugs with known QT prolongation 9. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.

Outcomes

Primary Outcomes

the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

Group 1:The primary endpoint/outcome measure is the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.

Time frame: within 1 month from randomization

the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

Group 2: The primary endpoint/outcome measure is the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

Time frame: within 14 days from randomization

Secondary Outcomes

The proportion of subjects with positive swabs in Group 1 within 1 month from randomization in both arms

The proportion of subjects with positive swabs in randomized population of SARS-CoV-2-exposed subjects ( Group 1) within 1 month from randomization in both arms

Time frame: within 1 month from randomization

The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization

The proportion of subjects of Group 1 who become symptomatic in each arm within 1 month from randomization, in subgroup population identified by stratification factors, class of age and gender.

Time frame: within 1 month from randomization

The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

The proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization, in subgroup population identified by stratification factors, class of age and gender.

Time frame: within 14 days from randomization

The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population

The proportion of subjects of Group 2 who become swab negative in each arm within 1 month from randomization in overall population and in subgroup population identified by stratification factors, class of age and gender.

Time frame: within 1 month from randomization

Absolute and relative frequencies of Serious Adverse Events

Absolute and relative frequencies of Serious Adverse Events (CTCAE version 5.0) in both arms for the Group 1 and Group 2.

Time frame: up to 10 months

Variation in Quality of Life scores in different time points

Variation in Quality of Life scores EQ-5D-5L (EQ-5D descriptive system with 5 severity levels from better to worse, and the EQ visual analogue scale (EQ VAS, scale from 100 to 0, high is better) in different time points (weekly) respect to baseline values in both Group 1 and Group 2 populations.

Time frame: up to 10 months

Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes